NCT06564844

A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer Who Are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Detailed description

The primary objective of the study is to assess the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig relative to SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Datopotamab Deruxtecan	Datopotamab Deruxtecan IV (intravenous)
DRUG	Rilvegostomig	Rilvegostomig IV (intravenous)
DRUG	Carboplatin	Carboplatin IV (intravenous), Active Comparator
DRUG	Cisplatin	Cisplatin IV (intravenous), Active Comparator
DRUG	Etoposide	Etoposide IV (intravenous), Active Comparator
DRUG	Pemetrexed	Pemetrexed IV (intravenous), Active Comparator
DRUG	Vinorelbine	Vinorelbine IV (intravenous), Active Comparator
DRUG	UFT	UFT Oral route of administration, Active Comparator

Timeline

• Start date: 2024-10-15
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2024-08-21
• Last updated: 2026-01-27

Locations

99 sites across 11 countries: United States, Brazil, Canada, Hong Kong, Japan, Malaysia, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study